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Joint United Nations Program on HIV/AIDS (UNAIDS) & World Health Organisation (WHO). AIDS Epidemic Update: December 2009, 2009. Available from: http://dataunaidsorg/Pub/Report/2009/JC1700-Epi-Update-2009-enpdf [Last accessed 01 September 2010]
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Gazzard, B.G.1
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Comparison of 48 week efficacy and safety of 400 mg QD nevirapine extended release formulation (Viramune XR) versus 200 mg BID nevirapine immediate release formulation (Viramune IR) in combination with Truvada® in antiretroviral (ARV) naive HIV-1 infected patients (VERxVE) [abstract ThLBB202]
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Vienna, Austria
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Gathe J, Bogner J, Santiago S, et al. Comparison of 48 week efficacy and safety of 400 mg QD nevirapine extended release formulation (Viramune XR) versus 200 mg BID nevirapine immediate release formulation (Viramune IR) in combination with Truvada® in antiretroviral (ARV) naive HIV-1 infected patients (VERxVE) [abstract ThLBB202]. XVIII International AIDS Conference, Vienna, Austria; 2010
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XVIII International AIDS Conference
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Gathe, J.1
Bogner, J.2
Santiago, S.3
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4
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2342620790
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Roles of conformational and positional adaptability in structure-based design of TMC125-R165335 (etravirine) and related non-nucleoside reverse transcriptase inhibitors that are highly potent and effective against wild-type and drug-resistant HIV-1 variants
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•• A key paper outlining the discovery of diarylpyrimidine drug candidates, including etravirine, from a structural perspective. The paper discusses how the flexibility in binding to reverse transcriptase allows the compounds to escape drug resistance mutations
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Das K, Clark AD Jr, Lewi PJ, et al. Roles of conformational and positional adaptability in structure-based design of TMC125-R165335 (etravirine) and related non-nucleoside reverse transcriptase inhibitors that are highly potent and effective against wild-type and drug-resistant HIV-1 variants. J Med Chem 2004;47:2550-60 •• A key paper outlining the discovery of diarylpyrimidine drug candidates, including etravirine, from a structural perspective. The paper discusses how the flexibility in binding to reverse transcriptase allows the compounds to escape drug resistance mutations.
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J. Med. Chem.
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Das, K.1
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Single-and multiple-dose pharmacokinetics of etravirine administered as two different formulations in HIV-1-infected patients
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• Study comparing the Phase II 800 mg and Phase III formulations 100, 200 mg of etravirine. Overall, the 200 mg twice daily dose significantly improved the bioavailability of etravirine and reduced interindividual variability in pharmacokinetics compared to 800 mg twice daily of the Phase II formulation
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Kakuda TN, Scholler-Gyure M, Workman C, et al. Single-and multiple-dose pharmacokinetics of etravirine administered as two different formulations in HIV-1-infected patients. Antivir Ther 2008;13:655-61 • Study comparing the Phase II (800 mg) and Phase III formulations (100, 200 mg) of etravirine. Overall, the 200 mg twice daily dose significantly improved the bioavailability of etravirine and reduced interindividual variability in pharmacokinetics compared to 800 mg twice daily of the Phase II formulation.
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Bioavailability of the 100 mg etravirine tablet dispersed in water and of the 25 mg pediatric tablet formulation [abstract MoPe0184]
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Mexico City, Mexico
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Scholler-Gyure M, Kakuda TN, Van Solingen-Ristea RM, et al. Bioavailability of the 100 mg etravirine tablet dispersed in water and of the 25 mg pediatric tablet formulation [abstract MoPe0184]. XVII International AIDS Conference, Mexico City, Mexico, 2008
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(2008)
XVII International AIDS Conference
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Scholler-Gyure, M.1
Kakuda, T.N.2
Van Solingen-Ristea, R.M.3
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8
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TMC125, a novel next-generation nonnucleoside reverse transcriptase inhibitor active against nonnucleoside reverse transcriptase inhibitor-resistant human immunodeficiency virus type 1
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Andries K, Azijn H, Thielemans T, et al. TMC125, a novel next-generation nonnucleoside reverse transcriptase inhibitor active against nonnucleoside reverse transcriptase inhibitor-resistant human immunodeficiency virus type 1. Antimicrob Agents Chemother 2004;48:4680-6
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TMC125 displays a high genetic barrier to the development of resistance: Evidence from in vitro selection experiments
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•• This study identified through sequential passage experiments that development of resistance to etravirine required multiple mutations and in addition to common NNRTI resistance mutations, novel mutations were also observed. Cumulatively, these data suggest etravirine possesses a high genetic barrier to resistance
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Vingerhoets J, Azijn H, Fransen E, et al. TMC125 displays a high genetic barrier to the development of resistance: evidence from in vitro selection experiments. J Virol 2005;79:12773-82 •• This study identified through sequential passage experiments that development of resistance to etravirine required multiple mutations and in addition to common NNRTI resistance mutations, novel mutations were also observed. Cumulatively, these data suggest etravirine possesses a high genetic barrier to resistance.
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77649254869
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Resistance profile of etravirine: Combined analysis of baseline genotypic and phenotypic data from the randomized, controlled Phase III clinical studies
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•• An important study evaluating the resistance profile of etravirine based on 24 week data from the DUET studies. Seventeen etravirine resistance-associated mutations were identified and in order to determine the effect of mutations on virological response weighted genotypic scores and clinical cutoffs were developed
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Vingerhoets J, Tambuyzer L, Azijn H, et al. Resistance profile of etravirine: combined analysis of baseline genotypic and phenotypic data from the randomized, controlled Phase III clinical studies. AIDS 2010;24:503-14 •• An important study evaluating the resistance profile of etravirine based on 24 week data from the DUET studies. Seventeen etravirine resistance-associated mutations were identified and in order to determine the effect of mutations on virological response weighted genotypic scores and clinical cutoffs were developed.
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12144289848
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A randomized, double-blind, placebo-controlled trial of TMC125 as 7-day monotherapy in antiretroviral naive, HIV-1 infected subjects
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•• Randomised placebo-controlled monotherapy study n = 19 in HIV-infected naive patients. Patients receiving etravirine achieved a significantly greater drop in viral load with a quicker daily decay rate in comparison to placebo following 7 days of treatment
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Gruzdev B, Rakhmanova A, Doubovskaya E, et al. A randomized, double-blind, placebo-controlled trial of TMC125 as 7-day monotherapy in antiretroviral naive, HIV-1 infected subjects. AIDS 2003;17:2487-94 •• Randomised placebo-controlled monotherapy study (n = 19) in HIV-infected naive patients. Patients receiving etravirine achieved a significantly greater drop in viral load with a quicker daily decay rate in comparison to placebo following 7 days of treatment.
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AIDS
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Gruzdev, B.1
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12
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12144287763
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An open-label assessment of TMC 125-A new, next-generation NNRTI, for 7 days in HIV-1 infected individuals with NNRTI resistance
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•• A study assessing the short-term efficacy and safety of etravirine over 7 days of therapy in HIV-infected patients with NNRTI resistance. The etravirine-based regimen demonstrated significant antiretroviral activity with a median decrease in viral load of 0.89 log10 and rapid daily decay rate of 0.13 log10 copies/ml/day
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Gazzard BG, Pozniak AL, Rosenbaum W, et al. An open-label assessment of TMC 125-a new, next-generation NNRTI, for 7 days in HIV-1 infected individuals with NNRTI resistance. AIDS 2003;17: F49-54 •• A study assessing the short-term efficacy and safety of etravirine over 7 days of therapy in HIV-infected patients with NNRTI resistance. The etravirine-based regimen demonstrated significant antiretroviral activity with a median decrease in viral load of 0.89 log10 and rapid daily decay rate of 0.13 log10 copies/ml/day.
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AIDS
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Gazzard, B.G.1
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Impact of reverse transcriptase resistance on the efficacy of TMC125 (etravirine) with two nucleoside reverse transcriptase inhibitors in protease inhibitor-naive, nonnucleoside reverse transcriptase inhibitor-experienced patients: Study TMC125-C227
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•• A pivotal study investigating the safety and efficacy of an etravirine-based regimen in comparison to investigator-selected PI-based therapy in NNRTI-experienced, PI-naive patients. The study was stopped prematurely due to suboptimal performance of the etravirine arm. Etravirine therapy does not appear to be as effective as PI-based regimens in patients with baseline NNRTI and NRTI resistance
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Ruxrungtham K, Pedro RJ, Latiff GH, et al. Impact of reverse transcriptase resistance on the efficacy of TMC125 (etravirine) with two nucleoside reverse transcriptase inhibitors in protease inhibitor-naive, nonnucleoside reverse transcriptase inhibitor-experienced patients: study TMC125-C227. HIV Med 2008;9:883-96 •• A pivotal study investigating the safety and efficacy of an etravirine-based regimen in comparison to investigator-selected PI-based therapy in NNRTI-experienced, PI-naive patients. The study was stopped prematurely due to suboptimal performance of the etravirine arm. Etravirine therapy does not appear to be as effective as PI-based regimens in patients with baseline NNRTI and NRTI resistance.
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HIV Med.
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Ruxrungtham, K.1
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14
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70449368908
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Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: Pooled 48 week analysis of two randomized, controlled trials
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•• A pivotal combined analysis of the two randomised, placebo-controlled Phase III studies, DUET-1 and DUET-2, evaluating the safety, efficacy and resistance profile of etravirine-based therapy over 48 weeks in patients with triple-class resistance. Significantly more patients achieved viral loads < 50 copies/ml in the etravirine arm. Safety and tolerability of etravirine were comparable to placebo with the exception of rash, which occurred more frequently in the etravirine arm
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Katlama C, Haubrich R, Lalezari J, et al. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS 2009;23:2289-300 •• A pivotal combined analysis of the two randomised, placebo-controlled Phase III studies, DUET-1 and DUET-2, evaluating the safety, efficacy and resistance profile of etravirine-based therapy over 48 weeks in patients with triple-class resistance. Significantly more patients achieved viral loads < 50 copies/ml in the etravirine arm. Safety and tolerability of etravirine were comparable to placebo with the exception of rash, which occurred more frequently in the etravirine arm.
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AIDS
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Katlama, C.1
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Montaner J, Yeni P, Clumeck NN, et al. Safety, tolerability, and preliminary efficacy of 48 weeks of etravirine therapy in a phase IIb dose-ranging study involving treatment-experienced patients with HIV-1 infection. Clin Infect Dis 2008;47:969-78
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Pharmacokinetics of etravirine are not affected by sex, age, race, treatment duration or use of enfuvirtide in HIV-1-infected subjects [abstract TuPe0082]
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Mexico City, Mexico;, • A population pharmacokinetic analysis of data obtained during the DUET studies. Covariates such as sex, age and race were not significantly associated with etravirine exposure. However, exposure was higher in those co-infected with hepatitis. Increasing adherence and decreasing weight were associated with increasing etravirine AUC0-12 and co-administered tenofovir lowered exposure
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Kakuda TN, Scholler-Gyure M, Peeters M, et al. Pharmacokinetics of etravirine are not affected by sex, age, race, treatment duration or use of enfuvirtide in HIV-1-infected subjects [abstract TuPe0082]. XVII International AIDS Conference, Mexico City, Mexico; 2008 • A population pharmacokinetic analysis of data obtained during the DUET studies. Covariates such as sex, age and race were not significantly associated with etravirine exposure. However, exposure was higher in those co-infected with hepatitis. Increasing adherence and decreasing weight were associated with increasing etravirine AUC0-12 and co-administered tenofovir lowered exposure.
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(2008)
XVII International AIDS Conference
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Kakuda, T.N.1
Scholler-Gyure, M.2
Peeters, M.3
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22
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44649109705
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Etravirine has no effect on QT and corrected QT interval in HIV-negative volunteers
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• This study also compared the pharmacokinetics of once daily vs twice daily etravirine in healthy volunteers and showed that maximum concentrations were 44% higher and trough concentrations 25% lower with similar exposure following once daily dosing. The data supported further investigation in HIV-infected patients
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Peeters M, Janssen K, Kakuda TN, et al. Etravirine has no effect on QT and corrected QT interval in HIV-negative volunteers. Ann Pharmacother 2008;42:757-65 • This study also compared the pharmacokinetics of once daily vs twice daily etravirine in healthy volunteers and showed that maximum concentrations were 44% higher and trough concentrations 25% lower with similar exposure following once daily dosing. The data supported further investigation in HIV-infected patients.
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Ann. Pharmacother.
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Scholler-Gyure M, Kakuda TN, De Smedt G, et al. Effects of hepatic impairment on the steady-state pharmacokinetics of etravirine 200 mg BID: an open-label, multiple-dose, controlled Phase I study in adults. Clin Ther 2010;32:328-37
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78649242949
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Safety and pharmacokinetics of etravirine in pregnant HIV-infected women [abstract PE 41/6]
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Cologne, Germany;, • A small study n = 5 evaluating etravirine pharmacokinetics in pregnant HIV-infected women during the third trimester of pregnancy. Etravirine pharmacokinetics was comparable to non-pregnant females and no serious malformations were observed. Further study of etravirine in pregnant women is ongoing TMC114-HIV3015
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Izurieta P, Kakuda TN, Clark A, et al. Safety and pharmacokinetics of etravirine in pregnant HIV-infected women [abstract PE 41/6]. 12th European AIDS Conference (EACS), Cologne, Germany; 2009 • A small study (n = 5) evaluating etravirine pharmacokinetics in pregnant HIV-infected women during the third trimester of pregnancy. Etravirine pharmacokinetics was comparable to non-pregnant females and no serious malformations were observed. Further study of etravirine in pregnant women is ongoing (TMC114-HIV3015).
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(2009)
12th European AIDS Conference (EACS)
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Izurieta, P.1
Kakuda, T.N.2
Clark, A.3
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Scholler M, Kraft M, Hoetelmans R, et al. Significant decrease in TMC125 exposures when co-administered with tipranavir (boosted with ritonavir) in healthy subjects [abstract 583]. 13th Conference on Retroviruses and Opportunistic Infections (CROI), Denver, Co, USA; 2006
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13th Conference on Retroviruses and Opportunistic Infections (CROI)
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Scholler-Gyure M, Debroye C, Vyncke V, et al. Effect of TMC125 on sildenafil pharmacokinetics [abstract 45]. 7th International Workshop on Clinical Pharmacology of HIV Therapy, Lisbon, Portugal, 2006
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7th International Workshop on Clinical Pharmacology of HIV Therapy
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Scholler-Gyure M, Woodfall B, Bollen S, et al. Pharmacokinetics of amprenavir and TMC125 in HIV-infected volunteers receiving TMC125 with fosamprenavir/ritonavir [abstract A-0370]. 46th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), San Francisco, CA, USA; 2006
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46th Interscience Conference on Antimicrobial. Agents and Chemotherapy (ICAAC)
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